Events

Rappel de Device Recall Customed

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Customed, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68536
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2441-2014
  • Date de mise en oeuvre de l'événement
    2014-05-20
  • Date de publication de l'événement
    2014-08-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129399
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    General surgery tray (kit) - Product Code LRO
  • Cause
    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
  • Action
    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Device

Device Recall Customed
  • Modèle / numéro de série
    Product code 900-2224, 31 lots 111030809 111040974 111051186 111051439 111061657 111123221 112010132 112020464 112030725 112041296 112083423 112093932 112114389 112114662 113015447 113025955 113026235 113036792 113057462 113067868 113078471 113088791 113099288 113109791 131110239 140111204 140211659 140312122 140312381 140412899 140513478
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Description du dispositif
    SURGICAL PACK || CONTENTS: || (1) SUTURE BAG FLORAL || (1) WRAPPER 30" X 30" || (2) UTILITY BOWL 16oz || (1) TRAY ORGANIZER FULL DEEP || (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TUBE WITHOUT VENT || (5) LAP SPONGE PREWASH 18" X 18" XRD || (1) BLADE SURG. #15 CARBON STEEL || (2) NEEDLE & BLADE COUNTER 1Oc MAG/CLEAR || (1) CAUTERY TIP POLISHER || (1) BLADE SURG. #10 CARBON STEEL || (2) LITE GLOVE || (10) GAUZE SPONGE 4" X 4" 16PLY XRD || (1) CAUTERY PENCIL ROCKER SWITCH || (1) TIME OUT BEACON NON WOVEN ST || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc

Manufacturer

Customed, Inc
  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
    Customed Inc
  • Source
    USFDA